title: A phase II study of plerixafor (AMD3100) plus G-CSF for autologous hematopoietic progenitor cell mobilization in patients with Hodgkin lymphoma.
abstract: Collection of an adequate number of hematopoietic stem cells can be difficult in patients with relapsed or refractory Hodgkin lymphoma (HL) who are candidates for autologous stem cell transplantation (ASCT). Plerixafor (AMD3100), an inhibitor of the interaction between stromal cell-derived factor 1 (SDF-1) and its receptor CXCR4, is an effective hematopoietic stem cell mobilization agent in patients with multiple myeloma and non-Hodgkin lymphoma (NHL). This study was undertaken to investigate the efficacy and safety of hematopoietic stem cell mobilization with plerixafor in patients with HL. Twenty-two patients with HL who were candidates for ASCT underwent hematopoietic stem cell mobilization with a combination of granulocyle-colony stimulating factor (G-CSF), 10 microg/kg daily, and plerixafor, 240 microg/kg subcutaneous, 10-11 hours prior to apheresis. The primary endpoint was the proportion of patients who collected>or=5x10(6) CD34+ cells/kg. Outcomes were compared to a historical control population of HL patients mobilized with G-CSF alone. Pharmacokinetic (PK) analysis of plerixafor was performed in a subset of patients. Fifteen patients (68%) collected>or=5x10(6) CD34+ cells/kg, and 21 patients (95%) achieved the minimum collection of >or=2x10(6) CD34+ cells/kg, in a median 2 apheresis procedures. Both the proportion of patients collecting>or=5x10(6) CD34+ cells/kg and the median CD34+ cells collected in days 1-2 of apheresis were significantly improved over historical controls. The PK of plerixafor in this patient population was similar to that previously seen in healthy volunteers. The regimen was generally safe and well tolerated.
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri 63110, USA. acashen@im.wustl.edu
authors.forename: Amanda
authors.initials: A
authors.lastname: Cashen
authors.forename: Sandra
authors.initials: S
authors.lastname: Lopez
authors.forename: Feng
authors.initials: F
authors.lastname: Gao
authors.forename: Gary
authors.initials: G
authors.lastname: Calandra
authors.forename: Ron
authors.initials: R
authors.lastname: MacFarland
authors.forename: Karin
authors.initials: K
authors.lastname: Badel
authors.forename: John
authors.initials: J
authors.lastname: DiPersio
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D018952:Antigens, CD34; D001596:Benzylamines; D001781:Blood Component Removal; D000080027:Cyclams; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000493:pharmacokinetics; D019650:Hematopoietic Stem Cell Mobilization; D006412:Hematopoietic Stem Cells; D006571:Heterocyclic Compounds / Q000008:administration & dosage* / Q000493:pharmacokinetics; D006689:Hodgkin Disease / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D033581:Stem Cell Transplantation; D014182:Transplantation, Autologous
chemical_list: D019380:Anti-HIV Agents; D018952:Antigens, CD34; D001596:Benzylamines; D000080027:Cyclams; D006571:Heterocyclic Compounds; D016179:Granulocyte Colony-Stimulating Factor; C088327:plerixafor